Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae, Escherichia coli or Streptococcus agalactiae. NOTE: Ceftizoxime, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.

Cefizox (ceftizoxime) has been effective in the treatment of seriously ill, compromised patients, including those who were debilitated, immunosuppressed, or neutropenic.

Infections caused by aerobicgram-negative and by mixtures of organisms resistant to other cephalosporins, aminoglycosides, or penicillins have responded to treatment with Cefizox (ceftizoxime) .

Because of the serious nature of some urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox (ceftizoxime) , higher dosage is recommended. Other therapy should be instituted if the response is not prompt.

Susceptibility studies on specimens obtained prior to therapy should be used to determine the response of causative organisms to Cefizox (ceftizoxime) . Therapy with Cefizox (ceftizoxime) may be initiated pending results of the studies; however, treatment should be adjusted according to study findings. In serious infections, Cefizox (ceftizoxime) has been used concomitantly with aminoglycosides (see PRECAUTIONS). Before using Cefizox (ceftizoxime) concomitantly with other antibiotics, the prescribing information for those agents should be reviewed for contraindications, warnings, precautions, and adverse reactions. Renal function should be carefully monitored.

DOSAGE AND ADMINISTRATION

The usual adult dosage is 1 or 2 grams of Cefizox (ceftizoxime for injection, USP) every 8 to 12 hours. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organisms.

a) When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.

b) If C. trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftizoxime has no activity against this organism.

c) In life-threatening infections, dosages up to 2 grams every 4 hours have been given.

Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox (ceftizoxime) , higher dosage is recommended. Other therapy should be instituted if the response is not prompt.

A single, 1 gram IM dose is the usual dose for treatment of uncomplicated gonorrhea.

The IV route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra-abdominal abscess), peritonitis, or other severe or life-threatening infections.

In those with normal renal function, the IV dosage for such infections is 2 to 12 grams of Cefizox (ceftizoxime for injection, USP) daily. In conditions such as bacterial septicemia, 6 to 12 grams/day may be given initially by the IV route for several days, and the dosage may then be gradually reduced according to clinical response and laboratory findings.

Modification of Cefizox (ceftizoxime) dosage is necessary in patients with impaired renal function. Following an initial loading dose of 500 mg-1 gram IM or IV, the maintenance dosing schedule shown below should be followed. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organisms.

When only the serumcreatinine level is available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent current renal function at the steady state.

Females: Females are 0.85 of the calculated clearance values for males.

In patients undergoing hemodialysis, no additional supplemental dosing is required following hemodialysis; however, dosing should be timed so that the patient receives the dose (according to the table below) at the end of the dialysis.

IM Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.

Vial Size

Diluent to Be Added

Approx. Avail. Vol.

Approx. Avg. Concentration

Room Temp. Stability

500 mg

1.5 mL

1.8 mL

280 mg/mL

16 hours

1 gram

3.0 mL

3.7mL

270 mg/mL

16 hours

2 grams*

6.0 mL

7.4mL

270 mg/mL

16 hours

*When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.

IV Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.

Vial Size

Diluent to Be Added

Approx. Avail. Vol.

Approx. Avg. Concentration

Room Temp. Stability

500 mg

5 mL

5.3 mL

95 mg/mL

24 hours

1 gram

10 mL

10.7mL

95 mg/mL

24 hours

2 grams*

20 mL

21.4mL

95 mg/mL

24 hours

These solutions of Cefizox (ceftizoxime) are stable 24 hours at room temperature or 96 hours if refrigerated (5°C).

Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, then the drug solution should be discarded. Reconstituted solutions may range from yellow to amber without changes in potency.

Piggyback Vials: Reconstitute with 50 to 100 mL of SodiumChloride Injection or any other IV solution listed below. SHAKE WELL.

Administer with primary IV fluids, as a single dose. These Piggyback vial solutions of Cefizox (ceftizoxime) are stable 24 hours at room ternperature or 96 hours if refrigerated (5°C).

A solution of 1 gram Cefizox (ceftizoxime) in 13 mL Sterile Water for Injection is isotonic.

IM Injection:

Inject well within the body of a relatively large muscle. Aspiration is necessary to avoid inadvertent injection into a bloodvessel. When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.

IV Administration:

Direct (bolus) injection, slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below). Intermittent or continuous infusion, dilute reconstituted Cefizox (ceftizoxime) in 50 to 100 mL of one of the following solutions: